(401 days)
Not Found
No
The device description and intended use clearly define a simple connecting line for fluid injection, with no mention of any computational or analytical capabilities that would involve AI or ML. The performance studies focus on material properties and sterility, not algorithmic performance.
No
The device is described as a connecting line for injection of fluids during diagnostic procedures (coronary angiography), not for treating a condition.
No
The device is described as a "connecting line for injection of a contrast, saline or other diagnostic fluids" during coronary angiography procedures. It facilitates the delivery of diagnostic fluids but does not, in itself, perform any diagnostic function such as analyzing data or making a diagnosis.
No
The device description explicitly lists physical components such as "female luer, male luer (including rotating male luer), and tubing and with or without caps," indicating it is a hardware device, not software-only.
Based on the provided information, the Sunmed™ High Pressure Line is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used as a connecting line for injecting fluids (contrast, saline, etc.) into the body during coronary angiography procedures. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description focuses on the physical components (luers, tubing) and its function in connecting syringes and catheters for injection.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (blood, urine, tissue, etc.) outside the body to provide information for diagnosis, monitoring, or screening. The Sunmed™ High Pressure Line does not perform any such function.
Therefore, the Sunmed™ High Pressure Line is a medical device used for in-vivo procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.
Package: Material: Dupont Tyvek package for medical use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Biocompatibility Testing: Pyrogen Test, Acute Systemic Toxicity Test, Intracutaneous Reactivity Test, In Vitro Cytotoxicity Test, Skin sensitization Test (two kinds of solvent), In Vitro Hemolysis Study( ASTM F756-08)
Aging Testing
Bench Testing
Package Penetrate Testing
Asepsis Testing
EtO and ECH Residue Testing
Clinical Evaluation was not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized human figure with three faces in profile, representing the department's focus on people and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 20, 2015
Sunny Medical Device (Shenzhen) Co., Ltd. Mr. James Oi Zhang General Manager 56 Lehigh Aisle Irvine, California 92612
Re: K140356
Trade/Device Name: Sunmed High Pressure Line Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: February 2, 2015 Received: February 18, 2015
Dear Mr. Zhang,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
M.A. Hilleman
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
2. Indications for Use Statement
Indications for use
510(k) Number (if known): K140356
Device Name: Sunmed™ High Pressure Line
Indications for Use:
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
文 Over-The-Counter Use Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1of 1
3
1. 510(k) Summary
| 1. | Submitted by: | Sunny Medical Device (Shenzhen) Co., Ltd. |
|---|---|---|
| Registered Address: | 4/F and 5/F, Dongpingxing Creative Science Park, | |
| Longgang District, Shenzhen, | ||
| Guangdong, P.R. China 518172 | ||
| Contact Address: | 56 Lehigh Aisle | |
| Irvine, CA 92612 | ||
| Telephone: | (949) 216-8838 | |
| Fax: | (949) 423-0168 | |
| Contact: | James Qi Zhang, General Manager | |
| E-mail: | jamesqizhang@gmail.com | |
| Date: | Nov. 18, 2013 |
-
- Proposed Device:
| Trade/Proprietary Name: | Sunmed™ High Pressure Line |
|---|---|
| Common/Usual Name: | Disposable High Pressure Line |
| Classification: | II |
| Classification Name: | Diagnostic intravascular catheter |
| Regulation Number: | 870.1200 |
| Product Code: | DQO |
-
- Predicate Device:
| 510(K)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K071196 | Disposable High Pressure Injection | |
| Lines and without Rotating Adapters | Coeur Medical, a division | |
| of Coeur Inc. | ||
| K023591 | Ultra High Pressure Injector Lines | DeRoyal Industries, Inc. |
Sunny Medical Device (Shenzhen) Co., Ltd.
4
-
- Device description
The Sunmed™ High Pressure Line is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
- Device description
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer, male luer (including rotating male luer), and tubing and with or without caps.
The Sunmed™ High Pressure Line is single use and supplied sterile by Ethylene Oxide.
Package: Material: Dupont Tyvek package for medical use.
-
- Intended Use
The Sunmed™ High Pressure Line is used as a connecting line for injection of a contrast, saline or other diagnostic fluids (by connecting the female luer of high pressure with an angiographic syringe and connecting the male luer or rotating male luer of high pressure with the catheter) during coronary angiography procedures. This product is composed of female luer (including rotating male luer), and tubing and with or without caps.
- Intended Use
-
Technological Comparison to Predicate Device 6.
The technological characteristics of the subject device, The Sunmed™ High Pressure Line, are equivalent to Disposable High Pressure Injection Lines and without Rotating Adapters and Ultra High Pressure Injector Lines in terms of intended use, materials, fundamental scientific technology, operating principle, sterility assurance level, and method of sterilization. -
- Summary of the technological characteristics of our device compared to the predicate device:
The predicates were compared in the following areas and found to have identical technological characteristics and to be equivalent because they are the identical products.
- Summary of the technological characteristics of our device compared to the predicate device:
5
Indications for Use Material Components Technique (Components/Flexible/Packaging/Pressure ) Sterility Biocompatibility
-
- Summary of Non-Clinical Testing
The following tests were performed on the Sunmed™ High Pressure Line:
- Summary of Non-Clinical Testing
Biocompatibility Testing: Pyrogen Test Acute Systemic Toxicity Test Intracutaneous Reactivity Test In Vitro Cytotoxicity Test Skin sensitization Test (two kinds of solvent) In Vitro Hemolysis Study( ASTM F756-08) Aging Testing Bench Testing Package Penetrate Testing Asepsis Testing EtO and ECH Residue Testing
-
- Clinical Evaluation was not applicable.
10. Conclusions
Based on the information presented in this 510(k) premarket notification, the SunmedTM High Pressure Line is considered substantially equivalent to the Disposable High Pressure Injection Lines with and without Rotating Adapters and Ultra High Pressure Injector Lines.